TAMPA, Fla (August 11, 2021) – The USF Health Morsani College of Medicine has been selected as a site for a clinical trial testing the Moderna mRNA-1273 COVID-19 vaccine for children ages 6 months to less than 12 years old.

Moderna intends to enroll up to 12,000 pediatric participants in the United States and Canada in this Phase 2/3 research study, called KidCOVE Study. The USF Health research physicians are seeking Tampa Bay area volunteers to participate in the KidCOVE study to evaluate safety and immune responses.  Enrollment begins for USF Health in coming days.

Image courtesy of Moderna.

“USF Health is pleased to join this national clinical trial to determine the safety and effectiveness of Moderna vaccines in children and younger populations,” said Charles Lockwood, MD, senior vice president of USF Health and dean of the USF Health Morsani College of Medicine. “Widespread vaccination is the best defense against COVID-19, and this rigorous scientific study may go a long way toward increasing vaccine access in this younger demographic.”

Leading the USF Health effort as principal investigator is Carina Rodriguez, MD, professor and chief of the Division of Pediatric Infectious Diseases in the Department of Pediatrics in the USF Health Morsani College of Medicine.

“This research study can help provide critical information about the safety, reactogenicity and immune responses observed with the vaccine in children and ultimately allow the vaccine to be approved for children,” Dr. Rodriguez said. “A vaccine that prevents COVID-19 disease in children would be a crucial public health tool to help curb the pandemic. We are eager to contribute to the innovative science that is working to bring a safe and effective solution for our younger patients, who are also vulnerable to this health threat.”

SOFIA. BULGARIA. FEBRUARY 24,2021. A Moderna Covid-19 Vaccine vial with sterile syringes

Participants will be seen by the study team based in USF Health’s Department of Pediatrics. Three out of four children participating in part 2 of the KidCOVE clinical trial will receive two intramuscular injections of the vaccine spaced at four weeks apart. The vaccine is made of messenger ribonucleic acid (mRNA), an instructional code that tells cells how to make protein, which help the body’s immune system make antibodies to fight the virus. The remaining quarter of participants will receive injections of a placebo made of saline (sterile salt water) solution.

All participants will be randomly selected to receive the vaccine or placebo. Participants will be followed for 12 months post-vaccination to monitor their health and safety.

Eligibility criteria

Study volunteers must be:

• No younger than 6 months and less than 12 years old
• In good health or with stable chronic conditions

Study volunteers must not:

• Have received an investigational or approved vaccine for COVID-19
• Be currently taking any investigational or approved treatments for COVID-19
• Have tested positive for COVID-19 or been in contact with anyone diagnosed with COVID-19 within 2 weeks prior to vaccine administration
• Have participated in any clinical trial in the past month

Enrollment for the USF Health Moderna KidCOVE Study begins in coming days, via email (usfchildrenscovidvaccine@gmail.com) or phone/text (813-853-1149).